New formulation containing curcuminoids: Method validation and dissolution profile

Abstract

Background: Curcuma longa, popularly known as turmeric, contains secondary metabolites called curcuminoids (curcumin, demethoxycurcumin, and bisdemethoxycurcumin) which are responsible for its therapeutic activity. Objective: The aim of this work was to obtain capsules using C. longa soft extract, to develop and validate a method for quantification of curcuminoids, and to study the dissolution profile of the capsules. Materials and Methods: The liquid extract was obtained through the percolation method and concentrated until it is characterized as soft extract. A high-performance liquid chromatography (HPLC) method was developed and validated for quantification of curcuminoids in the soft extract. The granule was obtained through wet granulation process and was encapsulated and the method for quantification of the markers was covalidated. Results: The soft extract showed 3.45% of bisdemethoxycurcumin, 3.03% of demethoxycurcumin, and 14.83% of curcumin, corresponding to 21.31% of total curcuminoids. The capsules had an average weight of 420 mg with approximately 21.56 mg of curcuminoids. The capsules showed better dissolution profile in neutral medium that simulates the pH of duodenum; however, in the stability test, only the variation found for bisdemethoxycurcumin was in compliance with the permitted. Conclusions: A soft extract of C. longa standardized in the three main curcuminoids was produced, as well as hard gelatinous capsules containing a dose of 21.56 mg of total curcuminoids. Thus, a new phytotherapeutic formulation was proposed, which proves to be an interesting strategy to carry out the active principles of C. longa. Abbreviations used: HPLC: High-performance liquid chromatograph; LOD: Limit of detection; LOQ: Limit of quantification; PDA: Photodiode array detector; PTFE: Hydrophobic polytetrafluoroethylene; TLC: Thin-layer chromatography; UV: Ultraviolet